Recall Z-2442-2020— Elekta Instrument AB

Name: FDA recall Z-2442-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-10

Class II · Terminated

Class II FDA medical device recall by Elekta Instrument AB, initiated 2020-06-10, terminated 2024-08-27. It names one FDA 510(k) clearance: K171123. Product: Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887. Reason: The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly..

Recalling firm: Elekta Instrument AB
Classification: Class II
Status: Terminated
Initiated: 2020-06-10
Terminated: 2024-08-27
Firm location: Stockholm, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K171123 — Leksell Vantage Stereotactic SystemElekta Instrument AB·cleared 2017-09-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887

Reason for recall

The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.

Data sourced from openFDA. This site is unofficial and independent of the FDA.